A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs

Celldex Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling

For Donors

Acute Lymphoblastic Leukemia (ALL)

Myelodysplastic Syndrome (MDS)

Acute Myelogenous Leukemia (AML)

For Recipients

Hodgkins Disease (HD)

Chronic Myelogenous Leukemia (CML)

Chronic Lymphocytic Leukemia (CLL)

Non-Hodgkins Lymphoma (NHL)

Treatments

Drug: CDX-301 and plerixafor

Drug: CDX-301

Study type

Interventional

Funder types

Industry

Identifiers

NCT02200380

CDX301-03

Details and patient eligibility

About

This is an open-label, multicenter, prospective pilot study of CDX-301 with or without plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from another person). HLA-matched sibling healthy volunteers (donors) and patients with protocol specified hematologic malignancies (recipients) will be enrolled.

Enrollment

36 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Donors:

Read, understood and provided written informed consent and willing to comply with all study requirements and procedures
6 out of 6 HLA-matched sibling
Negative test for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures
Subjects should be in generally good health and without significant medical conditions, based upon pre-study medical history, physical examination, electrocardiogram (ECG), chest X- ray, and laboratory tests
Meets all criteria to serve as a mobilized blood cell donor in accordance with all applicable individual Transplant Center criteria

Recipient:

Read, understood and provided written informed consent and willing to comply with all study requirements and procedures
6 out of 6 HLA-matched sibling
Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures

Diagnosis of one of following:

Acute Myelogenous Leukemia (AML) in 1st remission or beyond
Acute Lymphoblastic Leukemia (ALL) in 1st remission or beyond
Chronic Myelogenous Leukemia (CML)
Chronic Lymphoblastic Leukemia (CLL), relapsing after at least one prior regimen
Myelodysplastic Syndrome (MDS), either intermediate 1,2, or high risk by IPI Scoring System or transfusion dependent
Non-Hodgkins Lymphoma (NHL) or Hodgkins Disease (HD) in 2nd or greater complete remission, partial remission, or in relapse
Meets all criteria to serve as a transplant recipient in accordance with all applicable individual Transplant Center criteria

Exclusion criteria

Donors:

Unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
Prior treatment with any rhuFlt3L product
Any vaccination within 4 weeks prior to CDX-301 dosing
Donation of blood within 8 weeks, or donation of plasma within 2 weeks prior to CDX-301 dosing
Any experimental treatment within 4 weeks prior to CDX-301 dosing
Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months prior to CDX-301 dosing.
History of first degree relatives with primary or secondary immunodeficiency to include type 1 diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma or psoriasis
History of tuberculosis infection
Herpes zoster within 3 months prior to starting study drug
Pregnant or nursing

Recipient:

Unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
Prior allogeneic transplant
More than one prior autologous transplant
Prior treatment with any rhuFlt3L product
Any vaccination within 4 weeks prior to transplant
Uncontrolled infection at the time of the transplant conditioning regimen
Pregnant or nursing
Any condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the study outcome